Ethical Issues Raised by GOF Research

Synbio is a diverse field with diverse applications, and the different contexts (e.g., gain-of-function research, biofuels) raise different ethical and governance challenges. The objective of this course is to increase learners’ awareness and understanding of ethical and policy/governance issues that arise in the design, conduct and application of synthetic biology. The course will begin with a short history of recombinant DNA technology and how governance of that science developed and evolved, and progress through a series of areas of application of synbio.
Content will be presented in many forms, including not only reading and lectures, but also recorded and live interviews and discussions with scientists, ethicists and policy makers. Learners will have the opportunity to think, write and talk about the issues and challenges in their own work and in real-life case examples. A final project will engage students in the development of governance models for synbio.

TN

Highly thought-provoking. One of the most interesting classes I have taken on Coursera.

AN

Sep 12, 2018

Filled StarFilled StarFilled StarFilled StarFilled Star

Dr. Matthews is a fantastic instructor; Slide deck is great.

從本節課中

GOF Research

In Week 2 we will learn about and discuss gain of function (GOF) research and the dual-use concerns raised by synthetic biology. The work of the week includes lecture videos, a number of outside videos, and readings. The assessment this week will be your first peer-assessed project, and will focus on identifying ethical duties related to GOF research policy.

教學方

Debra JH Mathews, PhD, MA

Assistant Director for Science Programs

腳本

[MUSIC] There are a range of ethical issues raised by gain of function and dual use research. Responsible conduct of research issues are always important. So, these are Issues related to falsification of data, authorship, basically, don't lie, don't steal, don't cheat. Always important, but not really the focus of the concerns and the debates around gain of function and dual use research. While this isn't human subjects research, often, usually, there are still risks to humans and the environment. Risks both to lab workers and those outside of the lab, and again, to the environment as well. With regard to biosafety, which I just alluded to, there are public health concerns here, not just individual risks. Biosafety generally has been focused on risks to lab workers, but when you're talking about gain of function research, and in particular, gain of function research involving pathogens, the concern about Infection of lab workers becomes a public health concern. Because those folks may not know that they have been contaminated, or that the pathogen has been introduced. And then they go out into the world. And if they get sick, they will get others sick. So, the individual risk becomes a public health concern. There are also biosafety concerns related to gain of function research done in labs, or in jurisdictions where there aren't sufficient protections or oversight. This area of research is very rapidly expanding, many more labs are engaging in it. And not all of those labs have the oversight and protections we might want there to be. Public engagement in debates about the ethics and in oversight is, I think particularly important, and certainly has been a focus of the discussions and debates in gain of function research, because in this area of science, scientists are creating risks that are going to be largely born by society, right? They're going to be largely felt by the general public, if there is, in fact, either a biosafety issue that becomes a public health issue, or through bio terrorism, for example, the dual use concerns. But then again, there may also be opportunity costs, right? Of not doing this research, what won't you learn? What scenario will you not be prepared for if you haven't, in fact, gone through the process of getting a function research with a particular pathogen, for example? Another issue that is both an ethical and a governance issue has to do with determining the appropriate bio safety level in the advance of the work when you are taking a pathogen that may exist at a certain level of risk, or carry with it rather a certain level of risk. And doing gain of function research that actually changes the risks associated with the pathogen. Of course, a particular concern when you do that accidentally, you don't know what's that going to end up looking like. But again, a concern, again, related to biosafety. Most of the ethical issues surrounding gain of function and dual use research revolve around the risk/benefit analysis. Okay, so first, I'm going to run through some of the risks, run through some of the benefits, and then talk about how we weigh those. So, determining the risks, and potentially the benefits can be incredibly difficult, but it's absolutely critical that we do it, because in research, you're always trying to balance the risks and the benefits. You want your research on balance to have more benefits than burdens or harms or risks. So, risks involved in gain of function and dual use research into Biosafety and Biosecurity, which we have talked about. Proliferation, Informational risks, so, what are the risks of, for example, letting the world know through publication, of a method section? How to increase the pathogenicity of a particular organism. Agricultural risks, risks to major agricultural crops or agricultural animals stocks. Economic risks, and of course, the loss of public trust if something should go wrong. Or if even in the absence of something going wrong, the public finds out that there is research of grave concern to them that they weren't informed about, and weren't involved in the discussions related to it. Some of the benefits of this research include scientific knowledge, right? We are learning more about organisms, pathways, etc. Biosurveillance, we could improve our ability to detect concerning pathogens. This information can help us potentially develop medical countermeasures, right? The better we understand how particular pathogen affects a human host, for example, the better we hope that we can develop countermeasures, either vaccines or treatments for that disease. This research, we would think, would inform policy decisions around dual use research, around publication of this information, around medical countermeasures even. And potentially, of course, Economic benefits to offset the risk to economic consideration on the last line. Some raise the question of, are there lower risk alternatives to gain of function research, such as, for example, loss-of-function research, or the use of low pathogenicity viruses, or doing phenotypic analyses. And then importantly is the distribution of the risks and benefits. So, concerns about justice. Who is likely to reap the benefits of this research? And who is likely to bear the burdens, or suffer to be the ones at risk? And this comes down to values. So, risks and benefits, even if you can accurately predict what those or enumerate the risks and benefits, they still need to be weighed, right? You still need to make a decision about whether the potential benefits offset the likely risks and those decisions often come down to values. What do you value, for example, scientific knowledge very highly and intellectual freedom, or is the most important value in your mind, justice for example. And you may, everyone may agree that, all of these values listed here are very important. But again, when values come into conflict, decisions need to be made about which to prioritize, and different people will prioritize them differently. So, how different people weight different values will affect how they weigh the risks and benefits. And I think you can pretty easily imagine how a basic scientist might weigh, a weight values differently than a member of the general public. And this can be the source of conflict at times. There are a range of models that can be used for decision-making or oversight. These include, utilitarianism which is utility maximizing. You're trying to get the best, sort of paying for your back. Maximin is the idea that you go with the option that has the best worst outcome. [LAUGH] Maximax is the opposite of that. You're looking for the best best outcome. You can also go on a case-by-case basis, right? Every context that the research is in a context which is in a broader research context, which is in a social context, and it may be very different. Each case may be quite different, and therefore, need to be determined independently. The precautionary principal, the idea that we should approach a particular piece of science with caution, with great caution until we are assured that the risks are sufficiently low. Principlism, which is more from the human subjects research realm, and we will get into that more in the human health week. And public health ethics, because again, the biosafety concerns related to gain of function research and dual use research often turn into public health concerns. The critical thing is that in the end, decisions must be made, and we'll talk more about that in the lecture on governments.